FDA Inspection
Silva Markovic-PleseSilva Markovic-Plese – FDA Inspection, Jun 29, 2017
Record Details
This FDA Inspection record concerns Silva Markovic-Plese, with an inspection on June 29, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · ec421059-f738-40d2-b055-6e7653293e65
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1016130
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.60Informed consent
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